AUSONICS 5000

System, Imaging, Pulsed Echo, Ultrasonic

AUSONICS PTY LTD.

The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Ausonics 5000.

Pre-market Notification Details

Device IDK896714
510k NumberK896714
Device Name:AUSONICS 5000
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield,  CT  06078
ContactWilliam C Nealon
CorrespondentWilliam C Nealon
AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield,  CT  06078
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-29
Decision Date1990-06-11

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